Safety and Efficacy of Overnight Closed Loop in Children With Type 1Diabetes Mellitus in Luxembourg
Open Label Single Center Randomized Cross Over Study to Validate Current Algorithms and Evaluate Safety and Efficacy of Closed Loop Insulin Delivery (FlorenceD2 System) in Children With Type 1 Diabetes Between 6 - 12 Years of Age
1 other identifier
interventional
15
1 country
2
Brief Summary
The purpose of this study is to validate current algorithms and evaluate safety and efficacy of overnight closed loop insulin delivery (FlorenceD2 system) in children with type 1 diabetes between 6 - 12 years of age in Luxembourg .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2014
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 26, 2014
CompletedFirst Posted
Study publicly available on registry
March 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedSeptember 16, 2014
September 1, 2014
7 months
March 26, 2014
September 15, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time spent in normal glucose range ( mg/dl)
Glucose will be measured with a Continuous glucose monitoring device
At least 5 hours between 7 pm and 7 am
Secondary Outcomes (4)
glucose variability ( excursions in mg/dl)
7 pm - 7 am
Time spent in low glucose range (< 60 mg/dl)
7 pm till 7 am
time spent in low glucose range (<70 mg/dl)
7 pm till 7 am
time spent in high glucose range (>180mg/dl)
7 pm - 7 am
Study Arms (2)
Starting with FLORENCED2 followed by open loop
EXPERIMENTALStart 2 Overnight periods with closed loop through FLORENCED2 Device , followed by 2 overnight periods with open loop.
Start open loop followed by FLORENCED2
EXPERIMENTALStart with 2 overnight periods with open loop , followed by 2 overnight with closed loop FLORENCED2
Interventions
FLORENCED2 device ensures the closed loop between Freestyle Navigator II and the DANA DIABECARE R
Eligibility Criteria
You may qualify if:
- Between 6 - ≤12 years
- With type 1 diabetes for 6 months or more and
- Pump user for at least 6 months.
- HbAc1 should be \<11 %.
- No medication or physical or psychological disease should be present, which could interfere with the study.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Hospitalier du Luxembourglead
- University of Cambridgecollaborator
Study Sites (2)
DECCP Clinique Pédiatrique de Luxembourg/CHL
Luxembourg, 1210, Luxembourg
DECCP Pediatric Clinic , CHLuxembourg
Luxembourg, 1210, Luxembourg
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carine deBeaufort, MD PhD
Centre Hospitalier du Luxembourg
- PRINCIPAL INVESTIGATOR
Roman Hovorka, Professor
University of Cambridge
- PRINCIPAL INVESTIGATOR
Gosia Wilinska, PhD
University of Cambridge
- PRINCIPAL INVESTIGATOR
Ulrike Schierloh, MD
Centre Hospitalier du Luxembourg
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD , PhD
Study Record Dates
First Submitted
March 26, 2014
First Posted
March 28, 2014
Study Start
January 1, 2014
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
September 16, 2014
Record last verified: 2014-09